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Digital therapeutics is an emerging field in healthcare, promising innovative solutions for managing and treating various medical conditions. In 2024, the industry is projected to generate $4.68 billion USD in revenue with uncapped growth forecasted in the coming years. As the adoption of digital therapeutics continues to grow, conducting a well-designed and comprehensive study becomes crucial to evaluate their efficacy and ensure their integration into modern healthcare practices.
As we step into this digital frontier, the role of Contract Research Organizations (CROs) becomes increasingly pivotal in steering the course of digital therapeutics studies. From designing robust protocols to navigating complex regulatory landscapes, CROs ensure the success and ethical conduct of these important studies.
Digital therapeutics, also known as DTx, refers to software-based interventions designed to prevent, manage, or treat a medical disorder or disease. These interventions can be accessed through mobile applications, wearables, or online platforms. They are evidence-based and are aimed at improving patient outcomes by delivering clinically validated treatments or therapies. Digital therapeutics may include cognitive behavioral therapy, mindfulness programs, medication adherence support, and other interventions that leverage technology to enhance healthcare delivery.
When it comes to digital therapeutics, there is a clear distinction from general health and wellness apps. Digital therapeutics are based on rigorous scientific research and clinical trials, making them more reliable and effective. Regulatory bodies and clinicians recognize digital therapeutics as adjunct or standalone treatments and require a prescription from a doctor just like pharmaceutical drugs.
One of the key advantages of digital therapeutics is their accessibility. Patients can easily access and utilize these interventions at their convenience, eliminating geographical barriers and allowing for personalized care. This accessibility is particularly beneficial for individuals living in remote areas or those with limited access to healthcare facilities.
Digital therapeutics also provide continuous monitoring and real-time feedback. This feature enables healthcare providers to tailor interventions to each patient's specific needs, ensuring a more personalized and effective treatment approach. By leveraging technology, digital therapeutics have the potential to revolutionize healthcare delivery and improve patient engagement.
Integrating digital therapeutics into modern healthcare is highly beneficial to both healthcare providers and patients as this field has the potential to transform the way medical conditions are diagnosed, treated, and prevented. With accessibility being a prime selling point for adoption, patients can take ownership of their healthcare in a way that was before impossible.
Patients also see benefits of reduced healthcare costs and time taken up having to plan for visits (i.e. wait times, travel to and from visits). These interventions have proven success in improving patient engagement, medication adherence, and overall health outcomes. Furthermore, digital therapeutics provide an opportunity for remote monitoring and telemedicine, which have become increasingly relevant in the face of COVID-19. Digital therapeutics can bridge gaps in healthcare access, particularly in underserved areas, and promote equity in healthcare delivery.
Overall, digital therapeutics have the potential to revolutionize healthcare by providing evidence-based interventions that can be easily accessed, personalized, and monitored. As technology continues to advance, the integration of digital therapeutics into mainstream healthcare is expected to grow, encouraging more seamless, effective delivery of healthcare while keeping the patient in mind.
Although the field is becoming increasingly more prevalent, digital therapeutics is still a relatively new and niche area of healthcare that presents unique considerations for conducting clinical studies. Collaborating with a CRO that is well-versed in this space is crucial for ensuring the success of your trial.
CROs help shape protocols that not only adhere to regulatory standards but also capture meaningful data that contributes to the scientific understanding of the intervention’s efficacy. Digital therapeutics studies are not built the same as traditional pharmaceutical trials as they typically allow subjects a lot more flexibility (i.e. fully remote participation), so employing a CRO that is accomplished in designing and running these protocols is imperative. Cutting-edge CROs are utilizing machine learning tools to improve study design by analyzing attainable inclusion/exclusion and factors leading to early termination, ultimately reducing the burden of delayed protocol writing timelines and potential protocol amendments down the road.
Digital therapeutics CROs are also highly conscious of FDA guidelines surrounding these studies and therefore ensure the highest level of compliance. The FDA recognizes the potential benefits of digital therapeutics technologies and has been actively engaged in adapting its regulatory framework to accommodate the development of digital therapeutics.
With the vast majority of digital therapeutics interventions being web-based applications and/or smart devices, creating a user-friendly experience is the biggest priority in promoting patient experience and adherence to the investigational therapeutic. CROs with expertise in the field can assist in brainstorming the most effective digital activities to keep subjects engaged based on the objectives and endpoints you are looking to achieve. Some examples include real-time coaching via direct message, games, and virtual reality experiences.
This is an important consideration as this can greatly affect enrollment rate. With the innovative nature of digital therapeutics, most of these studies are able to be conducted 100% remotely, thus eliminating the burden of traveling to a brick-and-mortar site for study visits. Modern CROs have the capability to perform as a decentralized clinical trial (DCT) site by enrolling patients regardless of geographical location, supplementing recruitment for trials with physical sites or acting as the sole site for recruiting participants. In turn, patients that participate in fully virtual trials can benefit from remote monitoring and real-time feedback from their healthcare providers, thus enhancing adherence and satisfaction with participation.
While enrollment is almost always the rate-limiting factor to concluding a study on time, CROs aim to mitigate challenges with recruitment by employing a variety of different strategies based on how your digital therapeutics study is designed. In today's clinical trial landscape, it is not uncommon for CROs to be utilizing digital marketing tactics such as social media, paid advertising and email marketing to put your study in front of the right people. Additionally, forward-thinking CROs are taking advantage of artificial intelligence to screen electronic health records (EHRs) in efforts to cast a wider net of potential participants as quickly as possible.
Due to the complexity and variability of digital therapeutics products, a tailored education and training approach for each study device or application is paramount to success and subject adherence. CROs and site staff (if applicable) must be highly knowledgeable in all of the ins and outs of the investigational therapeutic to minimize user error among study participants and ensure the validity of the data collected.
Digital therapeutics clinical trials tend to collect a lot more data than traditional pharmaceutical studies and a common complaint among sites is that there are too many platforms for collecting and viewing patient data. In addition, the type of data collected in these studies can be a lot different as well, as patients are asked to report on more variables that cannot be qualitatively measured - user experience, emotional affect, quality of life variables, and more. Therefore, it's highly important to select a CRO that can seamlessly access and analyze this kind of patient data to ensure the success and validity of your digital therapeutics trial.
Conducting a digital therapeutics study requires a comprehensive approach that spans from study design to data analysis and interpretation. As this field continues to grow, collaboration with CROs with expertise in this field becomes increasingly important in ensuring scientific rigor and efficient study execution. By following the steps outlined in this article, researchers can contribute to the advancement of digital therapeutics and their integration into modern healthcare, ultimately leading to improved patient outcomes and quality of care.
If you're ready to elevate your digital therapeutics study with a full stack of services, look no further than Lindus Health. Our all-in-one solution encompasses everything from protocol writing to data delivery, including site services and a comprehensive eClinical platform. Let us streamline your clinical trial process and help you achieve the scientific rigor and regulatory compliance necessary for success. Book a meeting with our team today to discover how we can support your research and contribute to the future of healthcare.
